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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 62751
Product Type Devices
Status Terminated
Recalling Firm Sunquest Information Systems, Inc.
City Tucson
State AZ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-04-13
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: USA (nationwide) and country of: Bahamas.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. versions 2.4 and later Class III Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active. 23 clients Z-2243-2012